FDA nominee vows to "transform" agency

Senators criticize delay on morning-after pill decision

By

ValBrickates Kennedy

(This is an update to correct a previous version. Senators criticized delay in agency's decision on Plan B drug, not RU-486 drug.)

WASHINGTON (MarketWatch) - Food and Drug Administration Commissioner nominee Lester Crawford told Congress on Thursday that if confirmed, he would work diligently to transform the agency into one better capable of tracking the safety of drugs out on the market.

During a confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions, Crawford, who has been serving as acting commissioner since March 2004, vowed to implement structural and cultural changes in the agency that would promote more openness in the drug monitoring process.

"My vision for the future of FDA is one of transformation," said Crawford in his opening statements. "We're transforming our culture to one of transparency, collaboration, and cutting-edge thinking."

Crawford later admitted that the FDA needed to modify its culture in order to encourage more internal debate over the safety of drugs.

"We need to do more work on the culture of the FDA," said Crawford. "We need to work on making it more transparent."

Crawford's remarks dovetailed with statements from several senators that called for a return to the FDA's so-called days of glory, when it was considered the "international gold standard" of drug regulation.

In the wake of several drug safety crises, beginning with the abrupt recall of Merck's popular pain reliever Vioxx, the FDA has been roundly criticized for dragging its heels in responding to early warnings of drug safety problems. The agency has also been accused of discouraging criticism among its ranks of drugs already out on the market.

Crawford said that in particular, he would oversee the creation of a new drug safety board within the agency that would be more independent than the current one. The new board would be responsible for continually evaluating negative reports on drugs in the marketplace and then promptly issuing advisories to both the public and medical professionals.

Crawford said that he was in the process of selecting a new director for the office, which would be housed with the agency's Center for Drug Evaluation and Research.

That proposal drew criticism from some senators, who questioned why the new director of drug safety would not report directly to Crawford himself.

Sen. Barbara Mikulski was particularly critical of the move, stating that she believed the new drug safety office needed to be "independent of the bureaucracy."

Crawford also emphasized that the agency would continue to focus on protecting the nation's food supply from bioterrorist attacks or such diseases as bovine spongiform encephalopathy (BSE), or "mad cow" disease.

Contention over handling of morning-after pill

Several senators were also critical of Crawford's explanation for a final FDA decision on the controversial drug Plan B, which prevents pregnancy by interfering with an embryo's ability to implant itself into the uterine wall. An advisory panel of the FDA had overwhelming vote to recommend allowing over-the-counter sales of the drug, but a final decision has been delayed.

While an advisory panel vote is not a final decision, the FDA almost always follows the recommendations of its expert panels.

The debate on Plan B comes at a time when some conservative lawmakers are calling for a ban on sales of the drug RU-486, which can be used to terminate early-staged pregnancies.

Crawford apologized to senators for the agency's delay in making a final decision on the drug, stating that the drug's application "was unusually complicated." He added that he was not at liberty to publicly discuss why the application was unusual, as the FDA had not yet issued a final decision.

"There appears to be political interference in a scientific decision," said Clinton. "This is deeply disturbing to me."

"I can assure you that the decision will be based in science," answered Crawford. "I'm not aware of any political pressure."

Several senators later requested that a special briefing be scheduled with Crawford, before the confirmation vote, in order for him to be able to explain further why the FDA's decision has been delayed.

Committee chairman Mike Enzi informed Crawford that the senators would also be submitting written questions for him to answer.

Crawford was named Acting Commissioner in 2004, succeeding Mark McClellan, who left the agency to head up the Centers for Medicare and Medicaid Services. Crawford, a veterinarian by training, has worked off and on at the FDA for 13 years, at one point serving as one of its deputy commissioners.

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